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The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.
This study aims to define
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empa group | Experimental | patients will be given Empagliflozin 25 mg once daily |
|
| PTX group | Experimental | patients will be given PTX 400 mg twice daily or 3 times daily |
|
| UDCA group | Experimental | patients will be given UDCA 500 mg twice daily |
|
| Placebo | Placebo Comparator | patients will be given a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | tablets to be taken orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| liver fat content (percent) | measured by MRI-PDFF | 6-months |
| fatty liver staging (0, I, II, and III) | using ultrasound | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum Gamma glutamyl transferase (γ-GT) | IU/l | 6-months |
| HbA1c (%) | 6-months | |
| Fasting and 2-hr post-prandial serum glucose (mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
• Patients who refused to participate in this trial
Patients diagnosed with Type 1 diabetes
Previous history of alcohol intake
history of recurrent attacks of ketoacidosis in a diabetic patient
Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis
Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics)
Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis)
Lactating/pregnant female or children ≤ 18
Any contraindication for Empagliflozin including:
Any contraindication for PTX including:
Any contraindication for UDCA including:
Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM
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| Name | Affiliation | Role |
|---|---|---|
| Asmaa A Elsayed, PhD | BUC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya University Hospital | Minya | 61118 | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D014580 | Ursodeoxycholic Acid |
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Ursodeoxycholic acid | Drug | tablets to be taken orally twice a day |
|
|
| Pentoxifylline 400 MG | Drug | tablets to be taken orally twice a day |
|
|
| placebo | Other | just starch tablets without any active agents |
|
| 6-months |
| Lipid profile | (serum triglycerides, total cholesterol, LDL, HDL) (mg/dl) | 6-months |
| Changes in liver enzymes | AST (IU/l) and ALT (IU/l) | 6-months |
| Changes in direct and total bilirubin | (mg/dl) | 6-months |
| Changes in total protein and albumin | (g/l) | 6-months |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |